Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01259557|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : April 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Essential Blepharospasm||Drug: Botulinum Toxin Type A||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||August 2011|
|Experimental: Botulinum toxin type A(Meditoxin®)||
Drug: Botulinum Toxin Type A
2 times, Intra-muscular injection, Maximum dosage total 60U
- the change rate of Jankovic Rating Scale score [ Time Frame: 4weeks ]To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
- the change rate of Jankovic Rating Scale scale [ Time Frame: 0 week, 16weeks(or retreatment point) ]To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).
- the change rate of Blepharospasm Disability Index [ Time Frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point) ]To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.
- Global assessment about the improvement [ Time Frame: 4weeks ]To evaluate the Global assessment about the improvement at 4weeks post treatment.
- the duration of efficacy [ Time Frame: retreatment point or 16 weeks ]To evaluate the duration of efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259557
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|
|Seoul St.Mary Hospital|
|Seoul, Korea, Republic of, 137-040|
|Chung-Ang Univesity Yongsan Hospital|
|Seoul, Korea, Republic of, 140-883|
|Principal Investigator:||Jaechan Kim, M.D., Ph.D.||Chung-Ang university Yongsan Hospital|